Pfizer

CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.

Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.

Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.

Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration

I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.

12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.

Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.

Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.

Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.

Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.

Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.

Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.

I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.

Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.

Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.

Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.

Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL

After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,

Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was able to lay down in the vehicle as we were traveling from home to location and after about 5-10 minutes of laying back my HR lowered to between 100-120; arrived at ED around 6:45 and while waiting 4 hours in waiting rom area to be seen HR remained around 110-115 for the 4 hours straight and finally after about 5-6 hours it retuned to normal rate.

Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.

lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours

lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.

shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.

Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose

This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.

EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.

Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.

Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium

onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.

1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response

Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.

Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.

Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.

partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.

Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours

Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.

employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.

3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.

During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.

Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.

patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other associated symptoms. Vital signs normal. Evaluated in Emergency Dept. Discharged. Note that patient was very anxious prior to and after vaccination.

Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient presented for evaluation of an episode of chest tightness and possible allergic reaction after receiving the Pfizer vaccination for COVID-19. Patient reports that she initially did well but while she was waiting the 15 minutes of observation after the vaccine she began to note intermittent chest tightness as well as feeling like her heart was racing. This may have represented an allergic reaction although she did not require any medication to treat it.

Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)

2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered. Information on the Lot/Batch number has been requested.

Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.

My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.

After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.

Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.

fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.

After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.

Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).

Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021

Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.

body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.

heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.

Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.

Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.

Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.

weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.

Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.

patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out and had to go to the hospital; she was treated with IV fluids, meclizine, and ativan

Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.

chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.

Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.

The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.

felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm

hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown. Information on the lot/batch number has been requested.

my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.

uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did

tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).

Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.

complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.

Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea

I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap

Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium

During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.

About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.

Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying

felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.

patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.

patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.

Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.

Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.

General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat

After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.

At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.

Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.

shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.

supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b/m

Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.

chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.

Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not been diagnosed with Covid prior to vaccination. She was not pregnant. On 21Jan2021, the patient experienced increased heart palpitations and almost passed out immediately after second shot. No treatment was received for the events. Events resulted to doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. The patient was not tested for Covid post vaccination. Information on the batch/ lot number has been requested.

Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.

lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.

Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.

Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.

dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)

Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.

At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.

Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.

Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.

Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.

Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative

15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.

20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.

On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.

Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.

tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.

About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.

Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.

NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.

Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.

Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.

Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.

chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.

2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.

About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.

Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.

Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.

I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.

Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine

Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain

On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.

2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.

Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.

Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm

Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.

Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .

Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.

Patient reported to observation area for monitoring post-Injection.   No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.   She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.   Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling   Patient placed in supine position on stretcher, received water hard candy.   Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.   After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.

Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody nose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 04Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient had numbness at the site of the injection which was the left side (arm), and only on the left side; and had bloody nose. The patient had received treatment for the reported adverse event. The outcome of the events, 'numbness at the site of the injection' and 'bloody nose', was unknown.

The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.

10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.

1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.

Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.

Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.

Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.

I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.

Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.

severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.

Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.

Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)

Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.

I started developing walloping palpitations around 3 hours after vaccine was given. They have continued now for 18 hours post vaccination and I have never had these before in my life. I have numerous per hour but can be symptom free from time to time. No significant cardiac history before.

became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home

Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.

AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection

Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.

COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.

I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.

Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.

Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.

Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.

Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed

Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.

Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.

The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".

Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out

itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.

states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued

Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.

About one hour post injections I started developing chest pain and pressure. It worsened throughout the day and because I was worried about a cardiac event, I went to the emergency room.

For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm

My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.

heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .

Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better

seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.

All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite

All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.

Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.

rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.

1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left

This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.

Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased

red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.

Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.

Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain. Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses

I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.

Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.

Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.

heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.

Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.

Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.

Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.

deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours

Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.

12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphoresis

Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.

patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.

After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.

Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.

sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/resting. Over the course of the last 5 weeks it has lessened in severity

About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.

Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization . There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization. Information on the lot/batch number has been requested.

Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 weeks. Placenta showed 2 blood clots restricting blood flow at delivery. Mother with no known clotting disorders. 2 prior healthy infants.

Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment

Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given

Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report. Information on the lot/batch number has been requested.

- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS

DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) . A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years. No other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner. The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE

Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.

Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.

Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon). Treated in emergency room after EKG confirmed a-fib. Received potassium and flecainide and converted to normal sinus rhythm after several hours.

11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS

After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....

Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)

Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.

About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.

About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.

12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.

12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.

About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.

Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.

Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.

01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went away. 01/08/2021- Woke up at 11AM with slight pulsing pains again in left side of chest. no medicine taken. It came and went as the day went on - felt similar to heartburn. Thought I should report cause I've never woken up with these pains prior to this.

1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.

Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.

Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.

Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.

Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.

Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms

Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.

Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.

Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.

1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.

Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment. given IV fluids, Benadryl, famotidine, methylprednisolone, IV fluid bolus and 02 along with reglan and Zofran. Total ED stay approximately 4 hours

TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY

The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.

Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.

While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  

patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated

10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.

About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.

Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.

wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital

1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal

Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.

The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.

acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.

chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021). No treatment was received for the events. All events were reported as non-serious. No follow-up attempts are possible. No further information is expected.

headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.

After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.

Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, administration time=02:00 PM, dose number=2/administration date=18Dec2020, administration time=11:00 AM, dose number=1; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 14:00 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to penicillin. Concomitant medication included acyclovir (ACYCLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 0140; expiry date: unknown) in the right arm on 18Dec2020 at 11:00 AM, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced chest tightness. On the inside, she felt like she needed to exhale. The patient did not receive treatment for the event. Outcome of the event chest tightness was not recovered.

Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple minutes. No interventions performed

Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.

Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea

10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER

AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER

About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.

At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, drop in peak flow (~20% decrease) and coughing. This was treated with a single dose of Albuterol 2.5mg/3mL nebulized with complete resolution. No further shortness of breath. (Concurrently, also had mild tiredness and muscle aches.)

Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to normal.

Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.

Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room for high BP and was given 2 doses of Benadryl, was sent home after 1 hr, 2nd day reports severe HA which resolved same day with Aleve, today 1/18 reports still experiencing hives & continues to take PO Benadryl daily

Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.

Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.

Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.

Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue

Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.

Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded

Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.

While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called to her side. Her BP was elevated and she remained pale & dizzy. She was taken to ED. No medications were administered.

Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.

About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.

Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.

Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.

1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.

Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history

After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet count. I have no pre existing conditions before taking the vaccine . Last year my platelet count was 166. After 1 week of taking the second shot of vaccine my platelet count dropped to 129. After 5 days later I had reexamined the cbc and the platelet dropped to 121. I believe it is a reaction to the vaccine.

Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms

heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an hour

Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not improves with NSAID. Tachycardia, headache, insomnia, fatigue, chest pressure.

after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse and noticed it was 120. Pt stated she felt dizzy but nothing else. walked pt over to vehicle where her husband was parked. pt decided to be taken to ED in her own vehicle for further eval

chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I stood up; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: unknown), intramuscular on the right arm on 29Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included occasional premature ventricular contractions (PVCs) and high blood pressure. The patient had no known allergies, is not pregnant and had no COVID prior vaccination. Concomitant medications included vitamin C [Ascorbic Acid] (VITAMIN C [ASCORBIC ACID]), vitamin D3 (VITAMIN D3), bromelains (BROMELAIN), quercetin (QUERCETIN), zinc (ZINC), acetylcysteine (NAC [ACETYLCYSTEINE]) and Probiotic. The patient had no other vaccines in four weeks. On 06Jan2021 at 21:00, the patient experienced chills all day but no fever. Around 9pm, her heart rate shot up to the 120s and she had chest pressure and felt like she couldn't breathe every time she stood up. When she laid down, it was better. These lasted about 3 hours. She had some very mild shortness of breath twice after this on the 7th and 9th, but it was not nearly as bad as on the 6th. The patient did not take any medication when these happened. The patient tested for COVID post-vaccination (07Jan2021) through COVID-19 PCR (Nasal Swab) which resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.

palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.

Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged

Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.

Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. Passed by itself.

Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got up to leave and then felt palpitations; VS: BP 122/81, HR 74, O2 sat 97% on RA Pulse regular She sat down and symptoms resolved. Patient then left to go home, and was instructed to seek help if she felt worse.

12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose

(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department

On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet. Went to bed, the feeling went over her entire body. The sensation continued on her hands and her feet. She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low. Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy. He did blood work and going to check what would trigger the neuropathy pain.

Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccination. Today 2/5/2021, 2nd vaccination approximately 0800. Started to feel chills and numbness/tingling in left arm which was vaccination side. Then developed numbness/tingling in both legs below the knees. Placed on pulse oximeter and vitals monitored. Vital signs normal although initially blood pressure elevated but came back down. ~0830 Patient placed on gurney, covered with warm blankets and given oral medications: diphenhydramine 25mg, famotadine 20mg, acetaminophen 500mg. At 0930 patient taken to ED as symptoms were not resolving. Patient had difficulty transferring from gurney to wheelchair for transfer due to leg numbness.

blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.

I have lightheaded; elevated blood pressure; elevated blood pressure; This is a spontaneous report from a Pfizer sponsored program. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), intramuscular on 21Jan2021 08:00 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure elevated. Concomitant medications were none. When she took the first dose of the vaccine on Thursday 21Jan2021, about 2 minutes after receiving the injection she got really light-headed. They wanted her to be assessed by an EMT and when they assessed her, she had an elevated blood pressure. Last time her blood pressure was taken it was elevated and she had not had it checked since then. She was asking if it was safe to get the second dose. Patient declined any medical treatment, she was told to eat food and drink water. Outcome of lightheadedness was resolved on 21Jan2021. Outcome of blood pressure elevated was unknown.

shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering. The information on the batch number has been requested.

Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment

Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.

could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.

Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses other then the vaccine. Developed myalgia, severe headache, and slightly elevated blood pressures 24 hours post second vaccine. Then 4 weeks later acute pericarditis.

Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.

I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.

Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.

per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body

10 minutes after vaccination she developed mid-sternal chest tightness. No other allergic symptoms or SOB

complaining of mild tightness of chest immediately following vaccination. Pt stated that tightness not uncommon with history of asthma and anxiety. Denied : any itching or allergy related complaints, any respiratory difficulty.

tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen at ICC same day; was COVID tested at ICC negative

felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.

Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission

extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off

9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms

Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.

I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.

unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.

Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested.

extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.

Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.

10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not getting better. I got my 2nd shot on day 21 and the day after I got an alert on my Watch regarding resting heart rate exceeding 125bpm and have been inactive for 10mins, so my husband call the doctor's office to make an appointment. They said we could go to the appointment or hospital, so we went to the hospital.

like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.

3/11/2021 vaccination Home BP, 3/14 was elevated 3/15 I called the midwives and they told me to come in for monitoring. I had got in range of gestation hypertension and that they should induce me. I was induced on 3/15. This was my second pregnancy, EDD was 3/16, birth weight was 6lbs 9oz. *Post partem; high blood pressure. Magnesium treatment on 3/25

fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband. As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.

Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6204) at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included seizure from 1994 to an unknown date (it is been happening since the patient was a teenager), epileptic from an unknown date and unknown if ongoing. Concomitant medication included levetiracetam taken for seizure from an unspecified start date and ongoing. The patient reported that she had like blackout from, assuming the vaccine the next day on 23Mar2021. It was kind of later in the day and then next day, 23Mar2021, she was just having kind of had a blackout and she was sleeping a lot and may have had a seizure, she was not really sure as she was sleeping a lot and may had a seizure; she was not sure and she was epileptic. The patient was grateful that she got the vaccine. The patient underwent lab test and procedures which included blood test: unknown on an unspecified date. The patient was recovering from the events. Information on the lot/batch number has been requested

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.

Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered. Information on Lot/Batch number was available. Additional information has been requested.

I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed unconsciously seizure. The diagnosis are Cerebral Venous Thrombosis (CVT, multiple clots) and Cerebral Venous Sinus Thrombosis (CVST), Focal motor seizure and Cerebral Edema.

Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.

Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus

Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.

DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection

Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell

First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever chest pain I took Ibuprofen to relive the pain the next morning I had to see the doctor because I had sever pain but not related to the heart .

My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.

About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.

No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.

Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.

Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020. Follow-up attempts are not possible. No further information is expected.

ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.

heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self. A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa. the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event. The palpitations were resolving. The patient wasn't COVID tested post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.

Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.

I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?

Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.

extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest. Information on the lot/batch number has been requested.

increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital. Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.

Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.

fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.

Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved

Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip. Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72. She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink. She was observed for 30 minutes and symptoms gradually improved. Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61. She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication. She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist. She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed. She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours. She expressed understanding. She stated that she was comfortable going home and continuing to monitor her symptoms.

first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU

I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine

Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at 8:23am and 5 minutes later she experienced palpitations. HR 150 -190. Sent to ED for evaluation at 8:37am. In ED, her HR was in the 90s and patient feeling better. BP 134/95. No further treatment. Patient discharged at 9:13am

Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report

I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down

Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.

Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.

arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction

Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.

On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.

Patient experienced chest tightness after her first COVID vaccine dose. Pt reported similar reactions to vaccines in the past.

Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.

Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.

Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.

Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.

Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking

Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.

Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.

Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.

Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.

Palpitations and mild chest discomfort Palpitations have been intermittent throughout the day but occur all day long - few beats stop and then recur Some midsternal chest discomfort non radiating at rest The only change that would have occurred is the vaccine

Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.

Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.

approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.

near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14

20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.

About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.

Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.

Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.

Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms lasted for 4 hours. Patient did not feel short of breath or pain, just chest tightness to the point of irritation

Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.

COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.

Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.

As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to Palms of Pasadena hospital with non-urgent acuity.

As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest pain on deep inspiration. Initially became short of breath, which resolved prior to EMS arrival. EMS transported patient to the emergency room with non-urgent acuity.

Immediately following vaccination, the patient reported her left arm "becoming heavy", then she became dizzy with chest pain on deep inspiration. EMS transported patient to hospital under non-urgent acuity. Primary impression was generalized anxiety consistent with PMHx of anxiety episodes.

chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable

1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I had a prolonged nosebleed. i could not get it to stop for 20 minutes, i held my nose, took a shower. I have not had a nose bleed in years. I was so strange. Even when i was younger it would typically stop after 1-2 minutes. but this was just a prolonged bleed. I was concerned that my platelets were low and making an appointment to get them checked. As i read information about ITP but i wanted to insert this as a possible vaccine VAERS in case others experiences a similar manifestation after the vaccine

I received my first vaccine on Dec 18. By Dec 25, I had already started with rapid weight loss and a feeling of increased energy/metabolism with a fast heart rate. Over the next week, the symptoms escalated and my heartrate was consistently in the range of 95-125. I was losing 2lbs a day without any change in my diet. I lost 12lbs over 2 weeks as I tried to compensate and eat more. I had my thyroid checked with the concern of possible thyroiditis, but my TSH was well within normal limits. My FT3 was on the high end of normal but still within normal limits. Over this time frame, I am also having significant difficulty sleeping and only sleep for 3-5 hours most days. After my second vaccine on Jan 10th, my heartrate and weightloss stabilized and consistently still experiencing a heartrate around 100. I usually weigh around 120 lbs +/- 2 pounds and my weight is now consistently 110 +/- 2 lbs. I am an ER doctor, just for background reference of my medical knowledge. I had the nurse do an ECG on me at work and there were no concerning disruptions in the electrical conduction system of the heart. My blood pressure has been normal throughout, and sometimes rather high up to 160/110. My usual vital signs are BP 110/60 and HR 60-70.

extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.

hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.

intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.

Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.

Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.

Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection

cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit

01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.

dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.

Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly

fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit. Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.

I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.

Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92

Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.

Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.

Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.

pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling

"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM

A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.

Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.

she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.

10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tall building, then quick pulses, and then I felt my lungs were full/heavy.

Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed lightheadedness. She was transferred to a litter and had a pulse ox applied. She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported). Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution. EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.

11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started hurting with a lot of chest pain. The pain started going behind my back and pressure and we went to ER and when I went to take my urine test and I threw up a lot. I felt pretty good after that. My reports from tests came back okay. They told me to take over the counter Prilosec and gave a prescription for Zofran.

Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest pain, unlabored breathing. Pt reports no allergies to vaccines, denies throat irritation, denies nausea. Pt escorted by EMT outside at 1455. Pt advised to wait an extra 15 minutes. Pt symptoms resolved. Pt left facility at 1530 with her son.

Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.

sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 01Feb2021 13:45 at single dose for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 07:30, patient had sweating, palpitations, severe dizziness. The patient not received treatment for the event. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19.The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.

Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Dec2020 07:30 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies as wine. Concomitant medication included loratadine (CLARITIN [LORATADINE]) 10 mg, as needed, daily for unspecified indication. On 23Dec2020 07:45 patient experienced Paresthesia tip of RIGHT little finger within 10 minutes of vaccine. Tachy arrhythmia, loss of function in RIGHT little finger/hand, and syncope 45 minutes after vaccine while driving. Tachycardia, hypertension, generalized weakness, and severe fatigue walking upstairs (persistent and worsened over several days). Loss of function/sensation RIGHT arm and RIGHT leg 8 days after vaccination. Symptoms persisted and worsened. Diagnosed with Guillain Barre Syndrome and POTS at follow up on 19Jan2021. She still have persistent weakness/paresthesias/neuropathy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Dec2020. Seriousness criteria for all events was hospitalization.The events Guillan Barre syndrome and syncope were medically significant. Outcome of the event Guillain Barre Syndrome was recovering. Outcome of the other events was unknown.

Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.

bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn't received treatment for the events. The clinical outcome of the events not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.

almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.

Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and troponin normal, Covid swab negative, diagnosed with pleurisy

Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.

12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension

12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)

EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING AND SYMPTOMS RESOLVED.

Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen

15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.

developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.

Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.

Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.

On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.

Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.

Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.

1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.

Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours

About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.

I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.

Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.

@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well. Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.

About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations. Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.

5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough

Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.

Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went to work, 3:30 had blood pressure checked 174/102 and pulse was 98. Took Tylenol. Not dizzy. Monday covid negative

Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea

feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.

About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.

Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.

Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever did not go below 102.9 with both motrin and Tylenol. Fever finally broke completely on 1/14 at 330am. At 300pm I spiked a fever at 104.6 within 5 minutes and had vigorous rigors and horrible lower back pain. I was at work in the hospital and turned blue as per other nurses and doctors. I was evaluated b/p 144/100 HR 130 lactate 4.9. I am 120lb and have never had a b/p higher then 120. After NS Tylenol 2 liters of Lactated ringers my fever was 103.3 and the rigors stopped. I never had elevated wbc and my covid they did in the ER was negative. I went home. For the next 24 hours I continues with intermittent fevers. The next day I began with runny nose and sneezing. Since then I am very congested with headaches all day relieved partially with Motrin but never fully relieved.

I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/back, increase blood pressure and chest pain. Pepcid, benadryl and prednisone were given to me in the ER and a liter of fluids. VAERS number Date Form Completed: 01/06/2021 Temporary VAERS E-Report No: 223935 So on the second dose, I premedicated the night before 8pmwith 20mg of prednisone, 10mg of claritin, and 40mg of pepcid. In the morning 9am I took 40 mg of pepcid, 20 mg of predisone and 30 minutes prior to second vaccine around 12pm, I took 25mg of benadryl. After vaccine , I had severe nausea at about 20 minutes (1240p), and increase blood pressure at about 30 to 40 minutes. 156/94 was my highest. I had fewer areas of itching and specks of rash and itching around my back than on the first dose that I took. If I did not premediate, I am sure I would have had a similar or worse reaction since I still had similar reaction but milder.

Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now

tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.

near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.

Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered from covid several months ago.

Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on

Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.

woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies numbness/tingling, sore throat, throat swelling, hives or fever. SBPs around 150s (normally in the 90s). Feels like she is going to pass out. Symptoms resolved and pt discharged at 2325.

About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.

Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.

Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.

ED provider notes as follows: Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate 82 Respiratory Rate 20 Temp 36.7 °C (98.1 °F) Temp src Oral SpO2 98 % 44 y.o. female who arrived to the emergency department for Episode of right mid anterior chest pain intermittently ongoing starting around 10 PM this evening. She has had similar episodes in the past thought to be related to her gallbladder. Tonight she took some Pepcid and Tylenol. She denies any shortness of breath, or persistent chest pain, states pain has resolved since arriving in the emergency room. She denies any recent fever however she was recently given the second vaccine dose for COVID, and is having myalgias and symptoms she believes are related to the vaccination. She is requesting a COVID test. Patient denies sore throat, cough or abdominal pain. At this time only symptoms or myalgias. She continues to have no symptoms, her workup is reassuring, low suspicion for severe significant pathology, however would have a low threshold to return to the ER if chest pain would return or any other symptoms were to arise. COVID test came back negative.

Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximately 160-170s. Then about 40 hours after vaccination a rash developed. Previous history of viral rashes. Rash covered front and back of trunk took benadryl but lasted approximately 2 days. Lastly, on 1.25.2021, had a CT with contrast for another medical concern (not related) ended up having an allergic response to the contrast. Has had multiple CT over the years (greater than 10) has never had a reaction.

Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.

Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021

Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.

40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.

Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination. A day after vaccine, reports multiple episodes of subjectively bloody diarrhea. An evaluation by GI showed now abnormal findings. Patient tested for COVID and was negative. Advised not to get second dose of vaccine.

Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.

10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.

Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.

Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.

Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.

I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat. They lasted approximately 36 hours.

15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.

It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.

Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 @11:55, BP 167/105 @12:03, BP 181/96 @12:24; O2 sat 99%. Transported to the ED. Spent 3 hours in the ED BP down to 130/ Then discharged home. No recurrent episodes. Does not have history of high blood pressure.

low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation. Medical history included panic attack. There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.

rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 20Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included allergies: artificial orange in food and anxiety. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for birth control. The patient previously took first dose of BNT162B2 for covid-19 immunization on an unspecified date; and ammonia and experienced allergies. The patient was not pregnant at the time of vaccination. On 20Jan2021 14:00, the patient experienced rapid heartbeat and severe anxiety. The patient didn't go to the hospital and just worked through it herself as she has anxiety anyway. This lasted for about 4 hours. The patient did not receive treatment for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 20Jan2021.

Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client reports lasting about an hour, increased then plateaued and then decreased with taking Benadryl. Similar circumstances with first vaccination lasting approximately 1.5 hours. Increased heart rate and increase blood pressure during both circumstances.

HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later hr 120; patient states she feels better and wanted to go home;

At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by EMS, BP 135/83, pulse 90, Report O2 sat 99%, pulse 92. Client states she is feeling better. EMS discharge client. Client left vaccine site at 9:10 am.

Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slight itch to throat. NP and RN on sight assessed patient and had her sit in reclining chair with some water. 50 mg of Benadryl were administered orally at 1630. By 1720 patient was feeling better and her husband came to pick her up

Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.

5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED

Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racing.

Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and feet redness. Her endo specialist advised her to take Claritin gel caps for 3 days. The reaction lasted 2 days and was advised not to take the 2nd shot.

Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.

Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events.

The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.

Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection

First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate. I was asked to lay on gurney which I refused. I sat in chair. Paramedics monitored for 45 minutes until everything returned to normal. Walked to car by paramedics. Mom needed to drive home I was unable to.

Chest tightness experienced accompanied by high blood pressure and light headedness which started on 2/2/21 at around 1900. Visited urgent care on 2/3/21, EKG, cardiac enzymes, and CBC drawn. EKG read abnormal. Cardiology consult was suggested. Symptoms persisted until 2/7/21.

Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.

Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.

Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.

Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.

Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.

very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks. Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received. The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inhailers and asthma attack stopped.

Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.

Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.

dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.

Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.

Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.

She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.

3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.

EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself). A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA). The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 18Dec2020 09:00 (at the age of 44-year-old) at single dose for COVID-19 immunization. Medical history included dairy allergy. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine nor any other medications the patient received within 2 weeks. Within five minutes of the immunization on 18Dec2020 the patient's heart was racing, she was dizzy, her throat started to swell, and she was brought to the ER where they gave her epinephrine and Benadryl. She was admitted to the hospital (Dec2020) two times within a week due to the same symptoms; continuous heart palpitations. She was still having heart palpitations. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. Since the vaccination, has the patient been tested for COVID-19. Covid test was negative on unspecified date. The outcome of the event heart was racing was not recovered and the outcome of the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events palpitations, dizziness and pharyngeal swelling occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.

I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.

Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.

nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.

Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea

Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine

massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine, colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date. Information about lot/batch number has been requested.

On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.

PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.

I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)

After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced

Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.

After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.

High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.

Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.

next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.

12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.

When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.

06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.

After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.

I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop

PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.

Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.

dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test

dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test

After 15 minutes patient reported chest pressure which increased with inspiration. could not report rating on pain scale. Initial BP with complaints was 168/138. HR 88, RR 16, 98 o2sat, Temp 98.8. Follow BP 137/85 5 minutes later .Sent to ED at 12:53. 12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative. Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.

Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol

1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside. assessment repeated at 1840 B/P 136/94 HR 80, 1850 BP 140/100 HR 75 pt. reporting feeling better. Pt. reported feeling much better and left with friend at 1900.

45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved

Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.

Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.

Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her HR was also in 120's. At 1618, Epi given x1, then pt transferred to ED

Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persisting for 8+ hours until treated by cardiologist with addition of Flecainide. Flecainide 50 mg twice daily now part of medications.

At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?

Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.

Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.

Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.

Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.

pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.

15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palpitations, lightheadedness and feeling faint. Patient's symptoms resolved by 4:15pm. Patient was prescribed Benadryl 50mg PO and PEPCID 40mg PO. Patient discharged from EC home at 6pm.

shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling

After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.

Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. I then felt my heart rate increase. I took my heart rate from my apple watch and it was 145. Spoke to the nurse on site and she took my BP which was 185/140 (I am normally 120/80). Within a few minutes the heart rate started to drop but I was taken to the ED to be monitored. remained slightly tachicardic, but it was much better and BP dropped but was still elevated upon release -

COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3 Unclear if thrombocytopenia is from vaccination. No hx of this

Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.

wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested

Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain

Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)

Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.

Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.

Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.

3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.

Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.

Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.

pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.

Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.

Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.

Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.

Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.

Chest pains so bad I had to go to emergency room. Pain started 2 days after and another day to subside in chest. Arm that was injected took an additional 2 days to feel better.

Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.

intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.

Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope with previous blood donations received COVID-19 vaccine at 0645 and approximately 1 hour later developed a generalized feeling of warmth, followed by lightheadedness/dizziness. She denies frank LOC. She also reports palpitations and a rapid heart rate. She denied any rash, pruritis, dyspnea or chest pain, or N/V/D. Patient works in hospital and was transported to ED and upon arrival vitals were stable with HR of 79, BP 151/84, SaO2 of 100% on RA. Additional information for Item 18: Patient treated with IVF and released. Patient discharged to home and by 1:00pm that day was no longer symptomatic. She does endorse pre-syncope with previous blood draws.

Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.

About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated blood pressure and heart rate. Also felt slightly dizzy. Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing. Only treatment needed was vital sign monitoring. Vitals improved and no intervention was needed. I have had no further complications.

Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.

1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.

1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.

DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.

Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.

heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional hour

Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for paramedics who took her blood pressure having 80/50, Patient recovered, felt better and didn't wanted to go to the hospital.

Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness

Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.

Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).

In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.

My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.

Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.

headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as 5730, pending clarification), via an unspecified route of administration on 18Dec2020 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 45 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included asthma and known allergies to epinephrine, latex, sulfa. Concomitant medications included amoxicillin (AMOXICILLIN), ibuprofen (MOTRIN). On 19Dec2020 at 01:00 PM the patient had headache and tiredness ever since get palpitations, chest pain, arm weakness when standing too long or when first get up. Heart doctor thinks it's due to vaccine or anxiety but never had this before shot. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment for the events included anti anxiety medication, metoprolol. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination the patient was tested for COVID-19 (nasal swab) on 18Jan2021 which resulted negative. Information about lot/batch number has been requested.

Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.

Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.

passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.

stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.

injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.

Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.

Vasovagal response; This is a spontaneous report from a contactable consumer. A 45-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) into the left arm on 01Feb2021 08:15 AM at single dose for COVID-19 immunization. Age at vaccination 45 years. Concomitant drugs included multi-vitamin, D3, AERids eye vitamins. The patient had not history of allergies to medications, food, or other products. On 01Feb2021 at 08:30 AM the patient experienced a vasovagal response.Occupational Health/Wellness nurse checked blood pressure and had her lay down with legs up. After 10 minutes she went away and felt back to normal. No treatment was received. The outcome was recovered.

The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain." The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol

3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose . This lasted till 2/20 until around 5:30 pm

Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.

pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed. IV started. pt then taken to local hospital for further eval.

The patient presents with symptoms that started immediately after pt received her first covid vaccine around 1000 today at center. she developed lightheadedness, sob, nausea, h/a, and when er triage nurse was triaging her she syncopized for 3-4 seconds. no fall. pt was seated. and pt also reports that earlier she felt like the room was spinning. Tx in the ED w zofran and discharged.

Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainting. Minor chest pressure

Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.

Same day of vaccine later on that night I started getting a headache. The next morning I felt body aches, tired, as the day went on I started feeling tightness of chest, had to take deep breath this was around 10 or 11am then my supervisor said to go to the ER, They did an x-ray & covid test it came out negative & in the x-ray came back normal.

Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female with history of hypertension, anxiety. Patient received vaccination at 14: 05, approximately 5 minutes later at 14:10, Vasovagal response

Very high Blood Pressure that was fluctuating but not lowering for several hours. Sent to ER after 1.5 hours at the clinic. No treatment given at ER, Bloodwork, urine, and ECG all normal with no indication of any type of organ damage resulting from uncontrolled High Blood Pressure. Sent home after 3 hours with blood pressure of 179/95 and pulse rate of 104 with recommendation to monitor blood pressure and follow up with primary care. By Feb 13 blood pressure became normal and has stayed in the normal range.

after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to go on anti vert and anti nausea meds, now 1 month later, I am still dizzy in the morning, my muscles ache terrible , especially my lower leg muscles , joint pain, and I am so exhausted

Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.

fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receiving the second shot.

Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.

chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.

body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.

Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.

blood pressure was at 203/118; light headed; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, expiration date not provided), via an unspecified route of administration, at the age of 45 years old, administered in Left arm on 12Mar2021 14:30 at single dose for covid-19 immunisation. Medical history reported as none and there were no known allergies. There were no concomitant medications. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not test for covid-19 post vaccination. The patient experienced blood pressure was at 203/118 and light headed on 12Mar2021 14:45. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Specifically, it was reported that within 15 minutes of having the vaccine at 14:45 12Mar2021, the patient started feeling light headed, head pressure. Paramedics came to check on her and found out her blood pressure was at 203/118. The patient ended up in the emergency room on Friday 12Mar2021, again on 13Mar2021 for another incident of high blood pressure and on 16Mar2021 and her blood pressure was still high. The patient has never suffered of high blood pressure until after the vaccine. The patient's doctor has prescribed blood pressure meds and will monitor for two weeks to see if it can bring blood pressure down. Treatment Hydrocochlorothiazide 12.5mg and Lozartan were taken as a result of events blood pressure increased and light headedness. The outcome of the events was not recovered.

I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain, shortness of breath, sweating and chills. I went to the ER, and they discovered two blood clots in my lungs. I've never had pulmonary embolisms before, so this is a very strange coincidence. I am in cancer treatment, so my risk of PEs is higher, but the timing is too close for me not to think that the second vaccine traumatized my immune system, causing the PEs.

Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.

Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events tachycardia and rash to the vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.

Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. Due to fibroids, this caused excessive bleeding leading to anemic condition and the need for several blood and iron transfusions. Solution was to perform hysterectomy to eliminate fibroids and bleeding to be able to continue use of blood thinners for blood clot condition.

Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.

immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown. Follow-up attempts are needed. Further information on the lot/batch number has been requested.

is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck  

Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).

Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.

I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.

Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (1/1/21)developed fevers and right sided neck pain, tachycardia, myalgia

flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.

Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.

Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.

rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.

01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.

Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.

I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.